Tenofovir Linked With Risk of Kidney Damage

Tenofovir (brand name Viread), one of the most effective and commonly prescribed antiretroviral medications for HIV/AIDS, is associated with a significant risk of kidney damage and chronic kidney disease that increases over time, according to a study of more than 10,000 patients led by researchers at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco (UCSF). It was published electronically in the journal AIDS on February 9.

In their analysis of comprehensive Veterans Administration (VA) electronic health records, the study authors found that for each year of exposure to tenofovir, risk of protein in urine -- a sign of kidney damage -- rose 34%, risk of rapid decline in kidney function rose 11%, and risk of developing chronic kidney disease (CKD) rose 33%. The risks remained after other kidney disease risk factors such as age, race, diabetes, hypertension, smoking, and HIV-related factors were considered. The researchers call for increased screening for kidney damage in patients taking the drug, especially those with other risk factors for kidney disease.

For individual patients, the differences in risk between users and non-users of tenofovir for each year of use were 13% vs. 8% for protein in urine, 9% vs. 5% for rapidly declining kidney function and 2% vs. 1% for CKD. "However, these numbers are based on the average risks in our study population, and patients with more risk factors for kidney disease would be put at proportionately higher risk," said principal investigator Michael G. Shlipak, M.D., M.P.H., chief of general internal medicine at SFVAMC and professor of medicine and epidemiology and biostatistics at UCSF.

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Patients were tracked for an average of 1.2 years after they stopped taking tenofovir. They remained at elevated risk for at least six months to one year compared with those who never took the drug, suggesting that the damage is not quickly reversible, said Shlipak. "We do not know the long-term prognosis for these patients who stop tenofovir after developing kidney disease," he cautioned.

The implications for patients already on or starting antiretroviral therapy are "mixed," said Shlipak. "The best strategy right now is to work with your health care provider to continually monitor for kidney damage. Early detection is the best way to determine when the risks of tenofovir begin to outweigh the benefits."

Shlipak noted that HIV itself increases the risk of kidney damage, while modern antiretroviral treatments clearly reduce that overall risk. "Patients need to be aware of their kidney disease risks before they start therapy, and this should influence the medications that they choose in consultation with their doctor," he said. "For an otherwise healthy patient, the benefits of tenofovir are likely to exceed the risks, but for a patient with a combination of risk factors for kidney disease, tenofovir may not be the right medication."

Lead author Rebecca Scherzer, PhD, a researcher and statistician at SFVAMC and UCSF, said that the observational study was the largest and most conclusive indication so far of tenofovir's association with kidney damage. "There have been a number of previous, smaller studies suggesting that this drug might be associated with kidney disease, but the results were mixed," she said. "Those studies may have missed this association because they were too small, lacked appropriate lab data, or excluded subjects with pre-existing renal impairment or risk factors for kidney disease."

To be sure that tenofovir was the culprit, Scherzer and her colleagues looked for associations between 18 other antiretroviral medications and the same three measures of kidney disease. None were associated with higher risk.

Shlipak noted that the study results are particularly strong because two of the risk factors -- decline in function and CKD -- indicate kidney function, while protein in urine indicates physical damage to the kidney. "These are independent markers," he said. "To see the same drug cause both types of kidney disease gives you a very objective signal that something real is happening here."

Shlipak emphasized that, despite tenofovir's association with progressive kidney disease, it is an important component of effective antiretroviral therapy that may be required in many patients to control viral load.

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